Recall Z-0208-2019 ยท LXH Orthopedic Manual Surgical Instrument
DePuy Mitek, Inc., a Johnson & Johnson Co.
Mitek Screw and Washer Depth Gauge, Product Code 219024
| Date | Aug 30, 2018 |
| Status | Terminated |
| Reason | The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall Notification letters were sent to customers on 8/30/18. Updated Urgent Medical Device Recall notification letters were sent to customers on 9/18/18 |
| Quantity | 401 |
| Distribution | US nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MI, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI. The products were distributed to the following foreign countries: Australia, Canada, Chile, China, Chechnya, Denmark, Italy, Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.